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1 International Federation for Consulting GmbH IFC Validation on the basis of Commission Decision 2002/657/EC by Dr. Michael Scheutwinkel Slide 2 2 Did you sleep well? Slide 3 3 Validation shall demonstrate that the analytical method complies with the criteria applicable for the relevant performance characteristics (= is fit for purpose). Commission Decision 2002/657/EC, validation Banned substances (no permitted limits) Banned substances (no permitted limits) MRL substances Screening methods Confirmatory methods Slide 4 4 Commission Decision 2002/657/EC Table 10 Slide 5 5 Commission Decision 2002/657/EC Slide 6 6 Slide 7 7 Slide 8 8 Slide 9 9 CRL Guidance Paper 7 December 2007 state of the art Slide 10 10 CRL Guidance Paper 7 December 2007 state of the art MRPLs for MRL substances MRPLs for MRL substances Slide 11 11 CRL Guidance Paper 7 December 2007 state of the art MRPLs for banned substances MRPLs for banned substances Slide 12 12 Commission Decision 2002/657/EC Slide 13 13 Commission Decision 2002/657/EC Slide 14 14 Commission Decision 2002/657/EC Slide 15 15 Commission Decision 2002/657/EC Slide 16 16 How to establish CCa Slide 17 17 Commission Decision 2002/657/EC Slide 18 18 In practice Calibration curves with very low ao values and low SDwiR are common. That mean CCa gets unreasonable low. In this case CCa is calculated as CCa = C 1 + 2.33 x SDwiR How to establish CCa for banned substances Slide 19 19 How to establish CCa for MRL substances We need the within-laboratory reproducibility taken from the three series of checking the internal reproducibility at MRL-level We need the within-laboratory reproducibility taken from the three series of checking the internal reproducibility at MRL-level CCa = (fortification at MRL level + 1.64 x SDwiR) Recovery corrected Calibration curve: 0, 0.5, 1.0, 2.0 and 2.5-fold MRL Calibration curve: 0, 0.5, 1.0, 2.0 and 2.5-fold MRL Slide 20 20 Commission Decision 2002/657/EC Three times the signal to noise ratio can be used as decision limit. Three times the signal to noise ratio can be used as decision limit. Slide 21 21 Commission Decision 2002/657/EC Slide 22 22 Slide 23 23 Slide 24 24 For MRL substances CCa = fortification at MRL level + 1.64 x SDwiR CC = fortification at MRL + 3.28 x SDwiR For MRL substances CCa = fortification at MRL level + 1.64 x SDwiR CC = fortification at MRL + 3.28 x SDwiR Slide 25 25 Commission Decision 2002/657/EC Slide 26 26 Commission Decision 2002/657/EC Slide 27 27 Commission Decision 2002/657/EC Slide 28 28 Commission Decision 2002/657/EC Slide 29 29 How to establish CC For banned substances CC = CCa + 1.64 x SDwiR CCa For banned substances CC = CCa + 1.64 x SDwiR CCa For MRL substances CC = MRL + 3.28 x SDwiR MRL For MRL substances CC = MRL + 3.28 x SDwiR MRL Slide 30 30 For MRL substances CCa = fortification at MRL level + 1.64 x SDwiR CC = fortification at MRL + 3.28 x SDwiR For MRL substances CCa = fortification at MRL level + 1.64 x SDwiR CC = fortification at MRL + 3.28 x SDwiR Slide 31 31 Commission Decision 2002/657/EC Slide 32 32 Commission Decision 2002/657/EC Slide 33 33 Commission Decision 2002/657/EC Slide 34 34 Commission Decision 2002/657/EC Slide 35 35 Tools Decision limit CC Decision limit CC Recovery Recovery Repeatability Ruggedness Within-laboratory reproducibiity Within-laboratory reproducibiity Reproducibility Truneness Detection capability CC Detection capability CC Calibration curve Specifity Stability Applicability